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A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer

Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epithelial Ovarian Cancer; Extraovarian Peritoneal Cancer; Fallopian Tube Carcinoma

Intervention: Ontak (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Tyler Curiel

Official(s) and/or principal investigator(s):
Tyler Curiel, MD, PhD, Principal Investigator, Affiliation: The University of Texas Health Science Center at San Antonio

Summary

This study tests whether denileukin diftitox will deplete regulatory T cells, boost tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or who are ineligible for front line therapy.

Clinical Details

Official title: A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, of Fallopian Tube Carcinoma Failing or Ineligible for First-Line Therapy

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants Demonstrating Clinical Response

Secondary outcome: Toxicity

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Able to provide informed consent

- Not on Immune modulating drugs

- Life expectancy less than 6 months

Exclusion Criteria:

- Unable to tolerate phlebotomy

- Germ cell or stromal cell cancers of the ovaries

- Active autoimmune disease

Locations and Contacts

CTRC at UTHSCSA, San Antonio, Texas 78229, United States
Additional Information

Starting date: February 2007
Last updated: January 7, 2013

Page last updated: August 23, 2015

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